Blood Test for Coronavirus Immunity
Antibody tests won’t face the same bureaucratic hurdles diagnostic testing initially did. The U.S. Food and Drug Administration relaxed its rules last month, and body-fluid tests can proceed to market without full agency review and approval.
Several private companies have begun selling blood tests for COVID-19 antibodies outside the United States, including California-based Biomerica Inc (
BMRA.O) and South Korean test maker Sugentech Inc (
253840.KQ).
Biomerica said its test sells for less than $10 and the company already has orders from Europe and the Middle East. Chembio Diagnostics
Inc CMI.O of New York said it received a $4 million order from Brazil for its COVID-19 antibody test, and it plans a study of the test at several sites in the United States.
If testing goes forward on a wider scale, some public health experts and clinicians say healthcare workers and first responders should take priority.
Detecting immunity among doctors, nurses and other healthcare workers could spare them from quarantine and enable them to keep treating the growing surge of coronavirus patients, they say.
It could also bolster the ranks of first responders, police officers and other essential workers who have already been infected and have at least some period of protection from the virus, the experts say.
The Mayo Clinic MAYO.UL in Rochester, Minnesota, researchers are preparing to start a clinical trial in which patients who test positive for COVID-19 would have their blood collected at the time of diagnosis, and again 15 to 20 days after that in the patient’s home.
The U.S. Centers for Disease Control and Prevention said it is working on its own version of antibody tests, but it has not given a timetable. The agency has said extensive research is underway. One challenge for the CDC and other labs is to get enough blood samples from people who have already been infected to verify the antibody results.
The agency faced heavy criticism for sending a faulty diagnostic test to state and local labs early in the coronavirus epidemic and then taking weeks to fix it. The federal government is still trying to expand diagnostic testing capacity.
False positives are erroneous results that, in this case, could lead to a conclusion that someone has immunity when he or she does not.
“You are likely to have immunity for several months,” said Dr. Stanley Perlman, a professor of microbiology and immunology at the University of Iowa. “We just don’t know. This is an incredibly important question.”
Perlman said many of the new antibody tests coming on the market now may be highly effective, but
researchers want to see data to back that up.
U.S. companies, labs rush to produce blood test for coronavirus immunity
